Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients

NO_LONGER_AVAILABLE

Conditions studied: Solid Organ Transplant Rejection, Organ Rejection Transplants, Organ Rejection

In brief

This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression to severe or life-threatening condition related to rejection of an abdominal solid organ transplant, at risk of worsening allograft function, or at risk of complications from current immunosuppressive therapeutic regimens.

Key facts

Study ID

NCT05215288

Run by

Direct Biologics, LLC

Last updated by the study team

2024-07-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, ages 18 to 75.
• Previous abdominal solid organ transplant, including intestinal transplant.
• Diagnosis of acute or chronic rejection / inflammation based on clinical observations, laboratory analysis, histological evaluation.
• Diagnosis of worsening allograft function based on clinical observations, laboratory analysis, histological evaluation.
• Failed primary and alternate standard of care therapies.
• Serious or life-threatening condition or progressing to serious or life-threatening condition if not treated as evaluated by the treating physician.
• In otherwise good general health as evidenced by medical history.
• Male or female of reproductive potential must utilize a medically effective birth control method during from time of enrollment to 6 months after last dose of IMP.

You may not qualify if…

• Pregnant or breastfeeding.
• Treatment with another investigational drug or other intervention within 30 days of enrollment.

Where it is running

• Direct Biologics Investigational Site — Palo Alto, California, United States
• Direct Biologics Investigational Site — San Francisco, California, United States

Full record on ClinicalTrials.gov

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